Sponsors

Novant Health Clinical Research was established in 2001 and has grown from a staff of four, with a focus on cardiovascular studies, to a staff of 14, who conduct and manage trials in a wide range of therapeutic indications.

Staff

The Novant Health Clinical Research staff includes clinical research coordinators (CRCs), regulatory professionals, and support and management professionals. Six of these are certified by the Association of Clinical Research Professionals (ACRP) and all non-certified CRCs are on track to obtain certification. The current Director, Wendy Hobbs, holds certification as Certified Clinical Research Coordinator (CCRC) with 18 years of clinical research experience.

Regulatory

The institutional review board (IRB) of record for NCRI is Novant Health Forsyth Medical Center IRB (FMC-IRB). This IRB meets monthly (first Thursday) with a submission deadline of 10 days prior and approval time of five days post for new studies. FMC-IRB will defer review to external IRBs on a case-by-case basis.

Contracts / Budgets

Contracts are negotiated directly with NCRI with a usual turnaround of one week. NCRI complies with Novant Health's Fair Market Value in Clinical Research Pricing policy to ensure equitable pricing in compliance with AKS and Stark rules. A robust process of tracing clinical trial billing and coding ensures compliance with CMS regulations governing billing for clinical trial participants.

Experience

NCRI's investigators have conducted over 200 phase II-IV drug and device studies in the following therapeutic areas: